TPLC - Total Product Life Cycle

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Device	folders and injectors, intraocular lens (iol)
Regulation Description	Intraocular lens guide.
Product Code	MSS
Regulation Number	886.4300
Device Class	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Device Damaged by Another Device	727	728
Device Contamination with Chemical or Other Material	338	338
Crack	221	221
Adverse Event Without Identified Device or Use Problem	217	217
Scratched Material	139	140
Material Split, Cut or Torn	97	97
Material Twisted/Bent	85	85
Failure to Eject	77	77
Defective Device	75	75
Break	75	78
Defective Component	71	71
Difficult to Advance	48	48
Insufficient Information	40	40
Inaccurate Delivery	30	32
Particulates	20	20
No Apparent Adverse Event	20	23
Physical Resistance/Sticking	19	19
Failure to Advance	18	18
Contamination	18	21
Priming Problem	17	17
Device Difficult to Setup or Prepare	15	15
Failure to Deliver	13	13
Appropriate Term/Code Not Available	13	13
Material Deformation	11	11
Difficult to Insert	10	10
Use of Device Problem	8	8
Unintended Ejection	6	6
Ejection Problem	6	6
Product Quality Problem	5	5
Contamination /Decontamination Problem	5	5
Mechanical Jam	4	6
Material Rupture	3	3
Improper or Incorrect Procedure or Method	3	3
Off-Label Use	3	3
Material Fragmentation	3	5
Mechanical Problem	2	2
Failure to Fold	2	2
Fitting Problem	2	2
Activation, Positioning or Separation Problem	2	2
Malposition of Device	1	1
Structural Problem	1	1
Device Dislodged or Dislocated	1	1
No Pressure	1	1
Operating System Becomes Nonfunctional	1	1
Packaging Problem	1	1
Material Separation	1	1
Stretched	1	1
Unstable	1	1
Premature Discharge of Battery	1	1
Patient Device Interaction Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1052	1062
Insufficient Information	889	889
Capsular Bag Tear	46	46
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	42	42
Eye Injury	29	29
Visual Impairment	24	24
Corneal Edema	22	22
Toxic Anterior Segment Syndrome (TASS)	16	16
Endophthalmitis	14	14
Inflammation	10	10
Eye Pain	9	9
Blurred Vision	9	9
No Code Available	9	9
Hypopyon	7	7
Visual Disturbances	7	7
Foreign Body Sensation in Eye	6	6
Vitreous Loss	6	6
Intraocular Pressure Increased	6	6
Loss of Vision	5	5
Foreign Body In Patient	5	5
Uveitis	4	4
Vitreous Floaters	4	4
Swelling/ Edema	4	4
Prolapse	4	4
Keratitis	4	4
Red Eye(s)	4	4
Iritis	4	4
Wound Dehiscence	4	4
Unspecified Eye / Vision Problem	3	3
Failure of Implant	3	3
Fibrosis	3	3
Conjunctivitis	2	2
Zonular Dehiscence	2	2
Capsular Contracture	2	2
Corneal Abrasion	2	2
Hyphema	2	2
Vitrectomy	2	2
Edema	1	1
Hernia	1	1
Discomfort	1	1
Ventricular Tachycardia	1	1
Corneal Touch	1	1
Corneal Decompensation	1	1
Unspecified Tissue Injury	1	1
Bacterial Infection	1	1
No Consequences Or Impact To Patient	1	1
Corneal Scar	1	1